KETOROLAC TROMETHAMINE- ketorolac tromethamine tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)

Dostupno od:

PD-Rx Pharmaceuticals, Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Carefully consider the potential benefits and risks of ketorolac tromethamine tablets, USP and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with ketorolac tromethamine-IV or IM and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS). Patients should be switched to alternat

Proizvod sažetak:

Ketorolac Tromethamine Tablets, USP are available containing 10 mg of ketorolac tromethamine, USP. The tablets are white, film-coated, round, unscored tablets debossed with M over 134 on one side and blank on the other side. They are available as follows: NDC 43063-174-04 bottles of 4 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and excessive humidity. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

PD-Rx Pharmaceuticals, Inc.
Reference Label Set Id: 99f5a496-e108-4072-a013-47558e29a3fe
----------
MEDICATION GUIDE FOR NONSTEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
•
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft
(CABG)."
•
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You
may have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
•
anytime during use
•
without warning symptoms
•
that may cause death
•
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions
such as different types of arthritis, menstrual cramps, and other
types of short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart bypass surgery.
B

Svojstava lijeka

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
REFERENCE LABEL SET ID: 99F5A496-E108-4072-A013-47558E29A3FE
----------
WARNING
KETOROLAC TROMETHAMINE TABLETS, A NONSTEROIDAL ANTI-INFLAMMATORY DRUG
(NSAID), ARE
INDICATED FOR THE SHORT-TERM (UP TO 5 DAYS IN ADULTS), MANAGEMENT OF
MODERATELY SEVERE
ACUTE PAIN THAT REQUIRES ANALGESIA AT THE OPIOID LEVEL AND ONLY AS
CONTINUATION TREATMENT
FOLLOWING IV OR IM DOSING OF KETOROLAC TROMETHAMINE, IF NECESSARY. THE
TOTAL COMBINED
DURATION OF USE OF KETOROLAC TROMETHAMINE SHOULD NOT EXCEED 5 DAYS.
KETOROLAC TROMETHAMINE TABLETS ARE NOT INDICATED FOR USE IN PEDIATRIC
PATIENTS AND IT IS NOT
INDICATED FOR MINOR OR CHRONIC PAINFUL CONDITIONS. INCREASING THE DOSE
OF KETOROLAC
TROMETHAMINE TABLETS BEYOND A DAILY MAXIMUM OF 40 MG IN ADULTS WILL
NOT PROVIDE BETTER
EFFICACY BUT WILL INCREASE THE RISK OF DEVELOPING SERIOUS ADVERSE
EVENTS.
GASTROINTESTINAL RISK
Ketorolac tromethamine can cause peptic ulcers, gastrointestinal
bleeding and/or perforation
of the stomach or intestines, which can be fatal. These events can
occur at any time during use
and without warning symptoms. Therefore, ketorolac tromethamine is
CONTRAINDICATED
in patients with active peptic ulcer disease, in patients with recent
gastrointestinal bleeding or
perforation, and in patients with a history of peptic ulcer disease or
gastrointestinal bleeding.
Elderly patients are at greater risk for serious gastrointestinal
events (see WARNINGS).
CARDIOVASCULAR THROMBOTIC EVENTS
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction and
stroke, which can be
fatal. This risk may occur early in treatment and may increase with
duration of use (see
WARNINGS and PRECAUTIONS).
Ketorolac tromethamine tablets are contraindicated in the setting of
coronary artery bypass
graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS).
RENAL RISK
Ketorolac tromethamine is CONTRAINDICATED in patients with